Digitalisation of conformity assessment procedures of medical devices and in vitro diagnostic medical devices

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Maintaining an innovative, sustainable, and competitive EU health industry”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all the following expected outcomes:

• Notified Bodies (NBs), device^[1] developers and manufacturers adopt digitalisation in their conformity assessment procedures thus facilitating device development. As certain steps of conformity assessment do also require involvement of regulatory authorities (e.g. consultation of medicines authorities), digitalisation of these steps would also bring relevant benefit;
• Device developers and manufacturers have access to digitalised conformity assessment procedures. These procedures will become more efficient, less onerous, and more predictable, which will reduce costs and shorten the time to market access;
• Device developers and manufacturers, in particular small and medium-sized enterprises (SMEs), can direct a larger part of their resources towards the research and development of innovative devices.

Scope:

The regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR) have introduced stricter regulatory requirements in view of ensuring a high level of patient safety and public health. The implementation of the new regulatory requirements still remains a challenge for manufacturers. SMEs face particular challenges as they have limited resources to adapt to the new framework. One of the main issues reported by manufacturers is the complexity and perceived unpredictability of the conformity assessment procedure involving a Notified Body.

The Medical Device Coordination Group (MDCG) assists the Commission and the Member States in ensuring a harmonised implementation of the MDR and IVDR, notably through the development of guidance and templates. Notably, the conformity assessment procedures are still based on continuous exchange of highly complex technical documentation in an electronic format (e.g., pdf or excel files) between the key actors of NBs and manufacturers, requiring several iterations between them. Further digitalisation of this process (from document to data-driven processes) can bring greater efficiency, accuracy, and transparency and lead to a more predictable and harmonised assessment process. This is expected to reduce the administrative burden as well as certification timelines and facilitate the conformity assessment procedure for manufacturers, particularly SMEs. In turn, this will contribute to maintaining the EU as a business-friendly environment for all manufacturers, which will ultimately benefit patients. For example, digitalisation can lead to simplification through the reduction of administrative burden, use of a single-entry point for all exchange of information. If relevant, applicants may liaise with an ongoing study on supporting the monitoring of the availability of medical devices in the EU market^[2]. Potential improvements related to digitalisation can include pre-defining mandatory data elements, the possibility of getting alerts on whether data is complete, the identification of missing parts and inconsistencies and a reduction of error rates in this regard. Overall improved communication would be anticipated with digitalisation.

Any actions as part of the proposal will be performed under the current regulatory framework and will not involve changing MDR/IVDR requirements. Proposals should present a major step towards digitalisation in Europe and Associated Countries. Governance of a potential IT infrastructure developed in Europe and Associated Countries is outside the scope of the topic.

The proposals should cover all the following points:

• all steps of the MDR/IVDR procedures, from manufacturer’s preparation of technical documentation and other pre-application activities for certification to issuance of a MDR/IVDR certificate by a NB;
• all actors involved in the conformity assessment procedure, including manufacturers, NBs, EU reference laboratories, expert panels of medical devices, as well as agencies involved in the consultation activities;
• a good representation of different NBs, including representation from small and large NBs, public and private NBs and a representative mix focusing on medical devices and in vitro diagnostic medical devices. The proposal should put a strong focus on consensus building activities between the different stakeholders involved.

The proposals should address all the following activities:

• Feasibility study
  • Review existing initiatives aimed at digitalising MDR/IVDR conformity assessment procedures, or part thereof, and investigate digitalisation of conformity assessment/approval procedures for devices in other jurisdictions (e.g., US Food and Drug Administration). Consider lessons learned from digitalising conformity assessment procedures in other areas than medical devices.
  • Examine basic processes/workflows established by individual NBs.
  • Identify main steps of the conformity assessment procedure to be digitalised, actors involved, and essential elements and requirements to be considered prior to digitalisation.
  • Collect and analyse feedback from main stakeholders on challenges and feasibility of the digitalisation process, identify interoperability with existing workflows used by manufacturers and/or NBs.
  • Determine technical specifications required for the digitalisation as well as the possible options regarding digital transformation platforms.
  • Analyse facilitating factors, main challenges, possible solutions and required resources.
• Pilot
  • Develop a pilot for the whole or part of the MDR/IVDR conformity assessment procedure, including Key Performance Indicators (KPI). This will involve collaboration with relevant stakeholders, including NBs, manufacturers, the European Commission and other involved parties.
  • Develop a dedicated platform to run the pilot or identify an existing platform suitable for the pilot.
• Roadmap towards digitalisation
  • Based on the lessons learned from the pilot, identify different steps to scale-up the pilot in order to digitalise MDR/IVDR conformity assessment procedures, or part of them. Identify associated challenges and possible solutions to address these.
  • Present a roadmap to the piloted approach, including possible alternatives, covering actors involved and resources needed.

[1] For the purpose of this topic, the reference to ‘devices’ includes both medical devices and in vitro diagnostic medical devices, unless otherwise specified.

[2] Study commissioned by the European Commission’s Directorate-General for Health and Food Safety via the European Health and Digital Executive Agency (results not yet published): https://health.ec.europa.eu/study-supporting-monitoring-availability-medical-devices-eu-market_en